PMA P830063S028

Device: Gambro Prismaflex TPE 2000 Set
Applicant: Vantive US Healthcare, LLC
PMA number: P830063
Supplement: S028
Product code: MDP
Decision date: 2024-10-24
Classification: Gastroenterology, Urology
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Approval order statement: approval for change from manual production equipment to automated production equipment used to place the Tyvek window on the primary packaging bag (pouch) of the Gambro Prismaflex TPE 2000 Set

Current openFDA PMA Record#

Device: Gambro Prismaflex TPE 2000 Set
Applicant: Vantive US Healthcare, LLC
PMA number: P830063
Supplement: S028
Product code: MDP
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date: 2024-10-24
Decision code: OK30
Date received: 2024-09-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for change from manual production equipment to automated production equipment used to place the Tyvek window on the primary packaging bag (pouch) of the Gambro Prismaflex TPE 2000 Set